A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
- Registration Number
- NCT06054555
- Lead Sponsor
- Amgen
- Brief Summary
The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.
- Detailed Description
Eligible subjects will be randomized (1:1) to receive investigational product (ABP 206 or nivolumab).
All subjects will be treated until disease progression, unacceptable toxicity, or subject withdrawal of consent for a maximum of 24 months of treatment.
The total duration of study participation for each subject will be approximately 26 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 620
- At least 18 years of age.
- Histologically confirmed unresectable or metastatic melanoma.
- Subject has no prior systemic treatment for advanced disease.
- Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
- Tumor tissue from site of unresectable or metastatic melanoma must be available for biomarker analyses in order to be randomized.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
Key
- Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma.
- Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug.
- Subject has active central nervous system (CNS) metastases not previously treated.
- Ocular melanoma.
- Subject has active or known immune-mediated disorders.
- Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte- associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways.
- Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of investigational product.
Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABP 206 ABP 206 Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion. Nivolumab Nivolumab Subjects will receive Dose A of Nivolumab via IV infusion.
- Primary Outcome Measures
Name Time Method Objective response by Week 49 Week 49 Objective response at Week 17 Week 17 Progression-free survival (PFS) From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks) Overall survival (OS) From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks) Duration of response (DOR) From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
- Secondary Outcome Measures
Name Time Method Number of subjects with treatment-emergent adverse events of interest Week 1 until Week 105 Number of subjects with anti-drug antibodies Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105 Serum concentrations of ABP 206 and nivolumab (Ctrough) Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105 Number of subjects with treatment-emergent adverse events Week 1 until Week 105 Number of subjects with treatment-emergent serious adverse events Week 1 until Week 105
Trial Locations
- Locations (179)
AOU Luigi Vanvitelli
🇮🇹Napoli, Italy
Centrul de Oncologie Euroclinic
🇷🇴Iasi, Romania
Spitalul Clinic Judetean De Urgenta Sibiu
🇷🇴Sibiu, Romania
AOU Careggi
🇮🇹Firenze, Italy
IRCCS Ca'Granda Maggiore Policlinic
🇮🇹Milano, Italy
Cancer and Blood Specialty clinic
🇺🇸Long Beach, California, United States
Fort Wayne Medical Oncology and Hematology - Office of Clinical Research
🇺🇸Fort Wayne, Indiana, United States
Our Lady of the Lake Physicians Group-Medical Oncology-Woman's Pavilion
🇺🇸Baton Rouge, Louisiana, United States
University of Maryland Medical Center-Greenebaum Cancer Ctr
🇺🇸Baltimore, Maryland, United States
Oncology Hematology Associates
🇺🇸Springfield, Missouri, United States
Hematology-Oncology Associates-CNY
🇺🇸East Syracuse, New York, United States
Fundación CENIT
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina
Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology
🇦🇷Mar del Plata, Río Negro, Argentina
Clínica Viedma
🇦🇷Viedma, Río Negro, Argentina
Ospedale San Raffaele, IRCCS
🇮🇹Milano, Italy
Instituto de Oncologia de Rosario
🇦🇷Rosario, Santa Fe, Argentina
ISIS Clinica Especializada
🇦🇷Santa Fe, Argentina
Clinical Center University of Sarajevo - Clinic of Oncology
🇧🇦Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina
University Clinical Center of Republic of Srpska
🇧🇦Banja Luka, Republika Srpska, Bosnia and Herzegovina
University Clinical Hospital Mostar - Clinic for Lung Diseases
🇧🇦Mostar, Bosnia and Herzegovina
University Clinical Center Tuzla - Oncology, Hematology and Radio
🇧🇦Tuzla, Bosnia and Herzegovina
Cantonal hospital Zenica - Oncology
🇧🇦Zenica, Bosnia and Herzegovina
Dr. Everett Chalmers Hospital - Oncology
🇨🇦Fredericton, New Brunswick, Canada
American University of Beirut Medical Center - Haematology
🇨🇦Moncton, New Brunswick, Canada
IC La Serena Research
🇨🇱La Serena, Coquimbo, Chile
Icegclinic Research & Care
🇨🇱Estacion Central, Santiago, Chile
Oncocentro APYS
🇨🇱Valparaiso, Valparaíso, Chile
Centro de Investigacion y Desarrollo Oncologico
🇨🇱Temuco, Chile
University Hospital Centre Zagreb - Oncology department
🇭🇷Zagreb, Grad Zagreb, Croatia
Poliklinika Anova
🇭🇷Zagreb, Grad Zagreb, Croatia
Klinicki bolnicki centar Osijek
🇭🇷Osijek, Osjecko-baranjska Županija, Croatia
FN Hradec Kralove - Klinika onkologie a radioterap
🇨🇿Hradec Kralove, Czechia
Vseobecna fakultni nemocnice v Praze - Dermatovenerologicka
🇨🇿Praha 2, Czechia
Tartu University Hospital
🇪🇪Tartu, Tartumaa, Estonia
East Tallinn Central Hospital
🇪🇪Tallinn, Estonia
CHU de Poitiers
🇫🇷Poitiers, Haute-Vienne, France
Centre Hospitalier De Saint Malo
🇫🇷Rennes, Ille-et-Vilaine, France
C.H.R.U Hopital Claude Huriez - Dermatologie
🇫🇷Lille, Nord, France
High Technology Hospital MedCenter LTD
🇬🇪Batumi, Ajaria, Georgia
LLC "Todua Clinic"
🇬🇪Tbilisi, Georgia
LTD "Israel-Georgian Medical Research Clinic Healthycore"
🇬🇪Tbilisi, Georgia
JSC KE Nat Ctr of Exp and Clin Surg
🇬🇪Tbilisi, Georgia
LTD "Multprofile Clinic Consilium Medulla" - Oncology
🇬🇪Tbilisi, Georgia
Goethe University Frankfurt
🇩🇪Frankfurt/Main, Hessen, Germany
University Hospital of Cologne
🇩🇪Köln, Nordrhein-Westfalen, Germany
Pécsi Tudományegyetem - Pszichiátriai És Pszichoter
🇭🇺Szeged, Hungary
Ospedale Maggiore Di Crema - Oncologia e Day Hospital oncologico
🇮🇹Crema, Cremona, Italy
IRST Dino Amadori IRCCS
🇮🇹Meldola, Forli, Italy
PO Ospedale San Vincenzo - Oncologia Medica
🇮🇹Taormina, Messina, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
AO Ss Antonio, Biagio e Arrigo
🇮🇹Alessandria, Italy
Istituto dei Tumori "Giovanni Paolo II"
🇮🇹Bari, Italy
ASST Papa Giovanni XXIII - Oncologia
🇮🇹Bergamo, Italy
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
Azienda Sanitaria Locale Napoli 1 Centro (ASL Napoli 1) - Ospedale del Mare
🇮🇹Napoli, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Arcispedale Santa Maria Nuova
🇮🇹Reggio Emilia, Italy
Fondazione Policlinico Universitario Campus Bio-medico - Oncologia Medica
🇮🇹Roma, Italy
IRCCS IFO, Istituto Nazionale dei Tumori Regina Elena (IRE)
🇮🇹Roma, Italy
Istituto Dermopatico dell'Immacolata (IDI) - IRCCS - Oncologia
🇮🇹Roma, Italy
Osp Isola Tiberina-Gemelli Isola
🇮🇹Roma, Italy
AOU Senese, Policlinico Le Scotte
🇮🇹Siena, Italy
Ospedale di Circolo, Presidio di Varese - Oncologia
🇮🇹Varese, Italy
Al Khalidi Hospital and Medical Center - Research
🇯🇴Amman, 'Ammān, Jordan
The Speciality Hospital (TSH) / Advanced Clinical Center
🇯🇴Amman, 'Ammān, Jordan
King Hussein Cancer Center
🇯🇴Amman, Jordan
Pharmaceutical Research Center (KAUH)
🇯🇴Irbid, Jordan
Inje University Haeundae Paik Hospital - Oncology
🇰🇷Busan, Busan Gwang'yeogsi [Pusan-Kwan, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon-si, Gyeonggido [Kyonggi-do], Korea, Republic of
Severance Hospital, Yonsei University Health System - Division of Medical Oncology, Department of In
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Asan Medical Center - Oncology
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital - Hematology and Oncology
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Saint George Hospital University Medical Center
🇱🇧Achrafieh, Beirut, Lebanon
Nini Hospital
🇱🇧Tripoli, Loubnâne Ech Chemâli, Lebanon
Hammoud Hospital University Medical Center (HHUMC) - Hemato-Oncology
🇱🇧Saida, Loubnâne Ej Jnoûbi, Lebanon
Ain Wazein Hospital - internal medicine
🇱🇧Beirut, Lebanon
Hotel Dieu de France Hospital - Oncology
🇱🇧Beirut, Lebanon
National Cancer Institute - Conservative Tumour Therapy
🇱🇹Vilnius, Lithuania
Hospital Universiti Sains Malaysia
🇲🇾Kubang Kerian, Kelantan, Malaysia
Hospital Pulau Pinang
🇲🇾Pulau Pinang, Pahang, Malaysia
Sarawak General Hospital
🇲🇾Kuching, Sarawak, Malaysia
Institut Kanser Negara
🇲🇾Putrajaya, Selangor, Malaysia
Hospital Canselor Tuanku Muhriz UKM
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Pantai Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Hospital Kuala Lumpur - Surgery
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Health Pharma Professional Research S.A de C.V.
🇲🇽Ciudad de Mexico, Distrito Federal, Mexico
Preparaciones Oncologicas SC
🇲🇽Leon, Guanajuato, Guanajuato, Mexico
Centro de Inm Onc de Occ Sa de Cv
🇲🇽Guadalajara, Jalisco, Mexico
iCan Oncology Center Centro Medico AVE
🇲🇽Monterrey, Nuevo León, Mexico
Centro Medico Zambrano Hellion TecSalud
🇲🇽Monterrey, Nuevo León, Mexico
Centro de Estudios y Prevención del Cancer AC
🇲🇽Juchitan, Oaxaca, Mexico
Hospital Angeles Centro Médico San Luis Potosí - Cardiologia
🇲🇽San Luis Potosi, San Luis Potosí, Mexico
Neurosciences Hospital Angeles Culiacán - Neurociencias Estudios Clínicos S.C.
🇲🇽Culiacan, Sinaloa, Mexico
Centro de Atención e Investigación Clínica en Oncología
🇲🇽Merida, Yucatán, Mexico
Centro de Investigación Médica Aguascalientes (CIMA) - Oncology
🇲🇽Aguascalientes, Mexico
Boca Clinical Trials México
🇲🇽Guadalajara, Mexico
Oncare Cancer Center Viaducto CdMx
🇲🇽Mexico City, Mexico
ONCOCENTER PUEBLA - Dermatology
🇲🇽Puebla, Mexico
Althian - Research Management Center
🇲🇽San Pedro Garza Garcia, Mexico
Clinical Research Institute
🇲🇽Tlalnepantla de Baz, Mexico
Arensia Exploratory Medicine - Moldova - IMSP Institutul Oncologic - Oncology
🇲🇩Chisinau, Moldova, Republic of
Amphia Ziekenhuis - Molengracht
🇳🇱Breda, Noord-Brabant, Netherlands
Baguio General Hospital and Medical Center
🇵🇭Baguio City, Benguet, Philippines
The Medical City Iloilo
🇵🇭Iloilo City, Iloilo, Philippines
The Medical City - Neurology
🇵🇭Pasig City, Metropolitan Manila, Philippines
Cagayan de Oro Medical Center - Internal Medicine
🇵🇭Cagayan De Oro City, Misamis Oriental, Philippines
Center for Skin Research, Testing and Product Development
🇵🇭Makati City, National Capital Region, Philippines
Philippine General Hospital
🇵🇭Manila/Ermita, National Capital Region, Philippines
Cardinal Santos Madical Center
🇵🇭San Juan City, National Capital Region, Philippines
Riverside Medical Center
🇵🇭Bacolod City, Negros Occidental, Philippines
Cebu Doctors' University Hospital - Oncology
🇵🇭Cebu City, Philippines
Centro Hospitalar de Setúbal - Oncologia
🇵🇹Setubal, Setúbal, Portugal
Champalimaud Cancer Center
🇵🇹Lisboa, Portugal
Unidade Local De Saude De Lisboa Ocidental E.P.E.
🇵🇹Lisboa, Portugal
Hospital da Luz
🇵🇹Lisboa, Portugal
Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica
🇵🇹Lisboa, Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica
🇵🇹Lisboa, Portugal
Instituto Português Oncologia Francisco Gentil do Porto - Oncologia Medica
🇵🇹Porto, Portugal
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
🇷🇴Cluj-Napoca, Cluj, Romania
Medisprof - Medical Oncology
🇷🇴Cluj-Napoca, Cluj, Romania
Radiotherapy Center Cluj
🇷🇴Floresti, Cluj, Romania
Oncolab - Medical Oncology
🇷🇴Craiova, Dolj, Romania
Centrul de Oncologie Sf Nectarie - Medical Oncology
🇷🇴Craiova, Dolj, Romania
Medical Center Gral
🇷🇴Ploiesti, Prahova, Romania
Spitalul Municipal Ploiesti
🇷🇴Ploiesti, Prahova, Romania
Oncocenter- Oncologie Clinica - Medical Oncology
🇷🇴Timisoara, Timis, Romania
Memorial Healthcare International
🇷🇴Bucuresti, Romania
Institute of oncology Vojvodina - Medical Oncology
🇷🇸Sremska Kamenica, Vojvodina, Serbia
University Clinical Center Kragujevac - Oncology
🇷🇸Kragujevac, Šumadijski Okrug, Serbia
The Medical Oncology Centre of Rosebank
🇿🇦Johannesburg, Gauteng, South Africa
Wits Clinical Research
🇿🇦Parktown, Johannesburg, Gauteng, South Africa
University of Pretoria and Steve Biko Academic Hospital
🇿🇦Pretoria, Gauteng, South Africa
Curo-Oncology
🇿🇦Pretoria, Gauteng, South Africa
Little Company Of Mary Hospital - Oncology
🇿🇦Pretoria, Gauteng, South Africa
Cape Gate Oncology Centre
🇿🇦Bellville, Western Cape, South Africa
Rondebosch Oncology Centre
🇿🇦Cape Town, Western Cape, South Africa
Hospital Universitario Virgen de la Macarena - Oncología Médica
🇪🇸Sevilla, Andalucía, Spain
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol - Oncología Médica
🇪🇸Badalona, Barcelona, Spain
Hospital San Pedro de Alcántara - Oncología
🇪🇸Caceres, Cáceres, Spain
H.U.V.Arrixaca
🇪🇸El Palmar, Murcia, Región De, Spain
Hospital de la Santa Creu i Sant Pau - Oncología Médica
🇪🇸Barcelona, Spain
Hospital Universitario Vall d'Hebron - Oncología Médica
🇪🇸Barcelona, Spain
M.D. Anderson Center Madrid
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga - Servicio de Oncología
🇪🇸Málaga, Spain
Hospital Jerez Puerta Del Sur
🇪🇸Sevilla, Spain
Consorcio Hospital General Universitario de Valencia - Oncología
🇪🇸Valencia, Spain
China Medical University Hospital - Internal Medicine
🇨🇳Taichung, Taichung Municipality, Taiwan
Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare
🇨🇳New Taipei City, Taipei, Taiwan
Changhua Christian Medical Foundation - Changhua Christian Hospital - Internal Medicine
🇨🇳Changhua, Taiwan
Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University - Hematology and Oncology
🇨🇳Taipei, Taiwan
Maharaj Nakorn Chiangmai Hospital - Medical Oncology
🇹🇭Chiangmai, Chiang Mai, Thailand
Khon Kaen University, Srinagarind Hospital - Academic Clinical Research Office (ACRO)
🇹🇭Khonkaen, Khon Kaen, Thailand
King Chulalongkorn Memorial Hospital [Medical Oncology]
🇹🇭Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Ramathibodi Hospital - Immunology and Rheumatology
🇹🇭Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Siriraj Hospital - Medical Oncology
🇹🇭Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Prince of Songkla University
🇹🇭Songkla, Songkhla, Thailand
Gazi University Medical Faculty - Gynecology
🇹🇷Yenimahalle/Ankara, Ankara, Turkey
Adana City Training and Research Hospital
🇹🇷Adana, Turkey
Gulhane Training and Research Hospital - Medical Oncology
🇹🇷Ankara, Turkey
Ankara University Medical Faculty
🇹🇷Ankara, Turkey
Ankara Liv Hospital
🇹🇷Ankara, Turkey
Memorial Ankara Hastanesi
🇹🇷Ankara, Turkey
Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology
🇹🇷Ankara, Turkey
Uludag University Medical Faculty
🇹🇷Bursa, Turkey
Medical Point Gaziantep Hospital
🇹🇷Gaziantep, Turkey
Gaziantep University Sahinbey Practise and Research Hospital - Internal Medicine- Endocrinology and
🇹🇷Gaziantep, Turkey
Koc Universitesi Hastanesi; Tıbbi Onkoloji
🇹🇷Istanbul, Turkey
Bakirkoy Dr. Sadi Konuk Egt. Ars Hast.
🇹🇷Istanbul, Turkey
Goztepe SuleymanYalcin Sehir Hast
🇹🇷Istanbul, Turkey
Memorial Bahçelievler Hospital
🇹🇷Istanbul, Turkey
Izmir Medical Point Hastanesi
🇹🇷Izmir, Turkey
Kocaeli University Research and Practice Hospital - Medical Oncology
🇹🇷Kocaeli, Turkey
Sakarya Training and Research Hospital
🇹🇷Sakarya, Turkey
VM Medical Park Samsun Hospital - Medical oncology
🇹🇷Samsun, Turkey
ARENSIA Exploratory Medicine LLC
🇺🇦Kyiv, Kyïv, Ukraine
Hanoi Oncology Hospital
🇻🇳Hanoi, Ha Noi, Thu Do, Vietnam
Vietnam National Cancer Hopsital
🇻🇳Hanoi, Ha Noi, Thu Do, Vietnam
HCM Oncology Hospital - Medical Oncology
🇻🇳Ho Chi Minh, Ho Chi Minh, Thanh Pho [Sai Go, Vietnam